Elements of the Food and Drug Administration (FDA) review of the clinical data that supported the approval of the Biologics License Application (BLA) for belatacept for prophylaxis of organ rejection in adult patients receiving a kidney transplant are summarized. The article is not intended as a comprehensive summary of the entire belatacept data submission. Rather, the discussion is meant to illustrate aspects of the FDA's process for evaluating efficacy and safety, using belatacept as an example.

Title:
American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons
Volume:
12
ISSN:
1600-6143
ISO Abbreviation:
Am. J. Transplant.
Publication Date:
2012 Mar